GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE
FDA 510(k) clearance K060195 · decided 2006-04-24
Clearance details
- K-number
- K060195
- Device name
- GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE
- Applicant
- Gambro Renal Products
- Decision
- Substantially Equivalent
- Date received
- 2006-01-25
- Decision date
- 2006-04-24
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lakewood, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Gambro Renal Products
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product recall (Z-0370-2017) | Baxter Healthcare Corp. | 2016-11-08 |
| Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, In recall (Z-1644-2014) | Gambro Renal Products, Incorporated | 2014-05-21 |